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Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.
Outcome Measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey | Experimental | Each pack of 10 grams of honey after three meals a day. |
|
| Honey and propolis | Experimental | Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day. |
|
| Usual care | Placebo Comparator | General routine oral care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey product | Other | Bee products intervention from the first day of radiation to the end of radiation therapy duration 8-12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| oral mucositis severity | Ulceration or inflammation of the oral mucosa characterizes oral Mucositis | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pain score | visual analogue score(VAS) | up to 12 weeks |
| fatigue level | Brief Fatigue Inventory | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsai-Wei Huang, PhD | Contact | 886-2-2736-1661 | 6350 | tsaiwei@tmu.edu.tw |
| Tsai-Wei Huang, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Tsai-Wei Huang, PhD | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| propolis | Other | propolis |
|
| Usual care | Other | Usual care |
|
| Xerostomia score | Xerostomia Inventory | up to 12 weeks |
| nutrition level | Mini Nutritional Assessment | up to 12 weeks |
| QoL questionnaire | FACT-HN | up to 12 weeks |
| smart bracelet data | The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status | The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days |
| Saliva specimen collection | Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva | This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks |
| microbiota level | Stool and oral flora collection | Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |